PRINCETON, NJ, JUNE 28, 2011 – GE Healthcare today announced the availability of DaTscan™ (Ioflupane I 123 Injection), in more than 80 hospitals across the US. DaTscan is the first FDA-approved radiopharmaceutical adjunct imaging agent to help physicians evaluate patients with suspected parkinsonian syndromes (PS), such as Parkinson’s disease (PD). It gives physicians diagnostic capability that may lead to timely, appropriate treatments for suspected PS patients.
“This is a major advance in the diagnostic imaging space. GE Healthcare personnel are working extremely closely with hospitals to ensure that these institutions have the proper facilities to handle and use DaTscan and that physicians are trained properly,” said Donald J. Quinn, Vice President and General Manager, GE Healthcare Medical Diagnostics.
DaTscan is a Drug Enforcement Administration (DEA) Schedule II controlled substance. Hospitals and nuclear imaging centers that administer DaTscan must have infrastructure dedicated to quality control, handling and dispensing of DEA Schedule II, radioactive drugs used for diagnosis and treatment.
“We have a thorough process in place to provide institutions with assistance in DEA-controlled substance registration, imaging equipment set-up, and personnel training for radioactive drug handling and patient imaging protocols,” said Quinn.
Fifty thousand to sixty thousand new cases of PD are diagnosed in the US each year,[i] but an accurate diagnosis can take up to six years. Many people mistakenly attribute the first symptoms of PS, such as PD, to the normal aging process, and many have misconceptions about diagnosis. A recent survey by the National Parkinson Foundation found that 33 percent of Americans believe that a blood test can detect PD, while 30 percent did not know. Although doctors can run blood tests to help diagnose a number of conditions, they cannot diagnose PD based on the results of a blood test.[ii] Despite the unavailability of a simple test, DaTscan may be used as an adjunct to other clinical evaluations to assist in differentiating PS from conditions with similar symptoms, like essential tremor, in patients with suspected PS. DaTscan was not designed to differentiate between different forms of PS.
“A timely and correct diagnosis may help patients and their families overcome the fears and frustrations associated with the process of getting an accurate diagnosis so they can move on with their lives,” said Joyce Oberdorf, President and CEO, National Parkinson Foundation. "This new, innovative imaging agent is a big step in the right direction to be able to provide people with the right treatment and appropriate disease management.”
DaTscan may enable appropriate management for adult patients who have signs or symptoms of PS, by aiding timely, appropriate diagnosis. PS occurs when certain neuronal pathways in the brain are affected, including pathways involving dopamine. This affects the ability of the brain to control movement and other muscle functions. DaTscan is an adjunct to other diagnostic evaluations to help differentiate essential tremor (ET) – a common movement disorder – from tremors due to PS. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.
According to the World Health Organization, up to 25 percent of neurodegenerative movement disorders are misdiagnosed.[iii] Movement disorders are primarily diagnosed through clinical examination. Clinical exams alone, particularly early in the disease, are often inconclusive and can result in misdiagnosis. Movement disorders often have similar symptoms and the treatments can vary significantly. Inappropriate treatment can adversely affect patients’ quality of life. DaTscan is an additional diagnostic imaging tool that may help expedite an accurate diagnosis, which could improve disease management and ensure the use of appropriate medications.
DaTscan is only available with a prescription from a doctor. Patients should discuss their symptoms with their primary care physician to determine the best course of treatment. To learn more about DaTscan, visit www.datscan.com.
GE Healthcare’s expertise in medical imaging and diagnostics is helping physicians develop new tools to help predict, diagnose, monitor and inform about brain disease, from Parkinson’s disease and stroke to dementia and Alzheimer’s disease.
DaTscan is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain. A specific marker for DaT, DaTscan produces images that provide visual evidence based on the density of dopamine transporters. DaTscan has been available in Europe since 2000 and has been used in nearly 300,000 patients in 34 countries. DaTscan is classified as a Schedule II controlled substance. A Schedule II controlled substance is a substance with a currently accepted medical use in the US (with or without severe restrictions) that has a high potential for abuse that may lead to severe psychological or physical dependence, as determined by the Controlled Substances Act. A DEA license is required for the handling or administration of controlled substances.
FDA approval was based on two phase 3 clinical trials confirming the efficacy of DaTscan for the visualization of DaT distribution within the striata, an interior part of the brain. These studies, evaluating 284 adult patients with tremor, demonstrated the consistent performance of DaTscan in the visual detection of DaT distribution in the brain when compared with a reference clinical diagnosis.
Important Risk and Safety Information about DaTscan
INDICATIONS AND USAGE - DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations. CONTRAINDICATIONS - DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. WARNINGS AND PRECAUTIONS - Hypersensitivity Reactions - Hypersensitivity reactions, generally consisting of skin erythema and pruritis, have been reported following DaTscan administration. Thyroid Accumulation - The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least 1 hour before administration of DaTscan; failure to do so may increase the long term risk for thyroid neoplasia. ADVERSE REACTIONS - In clinical trials, headache, nausea, vertigo, dry mouth or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection site pain have been reported. DRUG INTERACTIONS - Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists upon DaTscan imaging results has not been established. SPECIFIC POPULATIONS - Pregnancy - It is unknown whether DaTscan can cause fetal harm or increase risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm depending on the stage of fetal development, and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers - It is not known whether DaTscan is excreted into human milk, however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan. Nursing women may consider interrupting nursing and pump and discard breast milk for 6 days after DaTscan administration to minimize risks to a nursing infant. Pediatric Use - The safety and efficacy of DaTscan have not been established in pediatric patients. Geriatric Use - There were no differences in responses between the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment - The effect of renal or hepatic impairment upon DaTscan imaging has not been established. DaTscan is excreted by the kidney; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images. DRUG ABUSE AND DEPENDENCE - Ioflupane I 123 Injection is a DEA Schedule II controlled substance. A DEA license is required for handling or administering this controlled substance. OVERDOSAGE - It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. PROCEDURE - Radiation Safety - DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.
Prior to DaTscan administration, please read the Full Prescribing Information.
About GE Healthcare
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[ii] National Parkinson Foundation Survey Results. March 2011.